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Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00217451
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Information provided by:
Albert Schweitzer Hospital

Brief Summary:
Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic that has been shown to be effective against malaria, although it cannot achieve a total cure in all patients. A previous small study has shown that in combination with clindamycin, an commonly used antibiotic, it is highly effective and safe, in asymptomatic carriers of malaria parasites. The current study will evaluate the efficacy and safety of the combination given for three days in children with uncomplicated malaria in Gabon.

Condition or disease Intervention/treatment Phase
Malaria Drug: Fosmidomycin-clindamycin Phase 2

Detailed Description:

The treatment of malaria is becoming increasingly difficult due to the development of Plasmodium falciparum strains resistant to commonly used antimalarials. Fosmidomycin was shown to be well tolerated and fast-acting in paediatric outpatients and adults, but late recrudescences preclude its use as monotherapy. Clindamycin was identified as a suitable combination partner following the demonstration of synergistic inhibition of plasmodial growth by in vitro and animal studies.

In this study, the safety and efficacy of fosmidomycin-clindamycin (30 mg/kg plus 10 mg/kg) twice daily for three days is assessed in children with acute uncomplicated P. falciparum malaria.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Fosmidomycin in Combination With Clindamycin in Children With Acute Uncomplicated Plasmodium Falciparum Malaria
Study Start Date : June 2002
Study Completion Date : March 2003

Primary Outcome Measures :
  1. Proportion of patients cured by day 14
  2. Incidence of adverse events after the start of treatment

Secondary Outcome Measures :
  1. Parasite clearance time
  2. Fever clearance time
  3. PCR corrected day 28 cure rate

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Uncomplicated P. falciparum malaria with acute manifestation
  • Asexual parasitemia between 1,000-100,000/μL
  • Body weight between 5-65 kg
  • Ability to tolerate oral therapy
  • Informed consent, oral agreement of the child if appropriate
  • Residence in the study area for the duration of at least 4 weeks

Exclusion Criteria:

  • Adequate anti-malarial treatment within the previous 7 days
  • Antibiotic treatment for a concurrent infection
  • Haemoglobin <7g/dL
  • Hematocrit <25%
  • Leukocyte count >15,000/μL
  • Mixed plasmodial infection
  • Severe malaria, any other severe underlying disease
  • Concomitant disease masking assessment of treatment response
  • Inflammatory bowel disease, and any other disease causing fever.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00217451

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Medical Research Unit, Lambaréné
Lambaréné, Moyen Ogooué, Gabon, B.P. 118
Sponsors and Collaborators
Albert Schweitzer Hospital
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Principal Investigator: Steffen Borrmann, MD Kenya Medical Research Institute, Centre for Geographic Medicine Research, Coast, kilifi, Kenya
Principal Investigator: Peter G. Kremsner, MD, FRCP Albert Schweitzer Hospital

Additional Information:
Layout table for additonal information Identifier: NCT00217451    
Other Study ID Numbers: 06/2002/FOS-CLIN/JP006
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005
Keywords provided by Albert Schweitzer Hospital:
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action